2. Presentation Outline
• What is the objective of any System ?
• What is expected of us in terms of Quality
Systems?
• Fundamentals of ICH Q10 ?
• Implementation advice
• Summary
3. What is the Objective of any System?
(Using ICH Q10 as an example)
Development + Tech transfer + Commercial + Discontinuation
Product
Realization
State of
Control
Continual
Improvement
Compliance
ORGANIZATIONAL OPTIMIZATION
System Boundaries ie full Life Cycle
“Quality is a side effect of a system that is running well”
6. SA Guide to GMP
(Common to all GMP Guides)
CHAPTER 1
QUALITY MANAGEMENT
1.1 PRINCIPLE
1.1.1 The holder of a manufacturing licence must manufacture
medicinal products so as to ensure that they are fit for their intended use,
comply with the requirements of the medicine registration and do not place
patients at risk due to inadequate safety, quality or efficacy.
1.1.2 The attainment of this quality objective is the responsibility of
senior management and requires the participation and commitment by staff
in many different departments and at all levels within the company, by the
company's suppliers and by the distributors.
1.1.3 To achieve the quality objective reliably, there must be a
comprehensively designed and correctly implemented system of Quality
Assurance, Incorporating Good Manufacturing Practice and thus Quality
Control and Quality Risk Management.
8. FDA – 6 Systems Approach
Quality System
Production System
Facilities &
Equipment
System
Laboratory Controls
System
Materials System
Packaging & Labeling
System
9. FUNDAMENTALS OF ICH Q10
FDA for the 21st Century approach provides the road map for Q10
19. manag
Fundamentals of Q10
Development Tech Transfer Discontinue
Commercial
Supply
Monitoring
Systems
CAPA
Systems
Management
Review
Change
Management
GMP
20.
21. manag
Fundamentals of Q10
Development Tech Transfer Discontinue
Commercial
Supply
Monitoring
Systems
CAPA
Systems
Management
Review
Change
Management
Quality Risk
Management
GMP
22. Risk Review
Risk Assessment
Risk Evaluation
unacceptable
Risk Control
Risk Analysis
Risk Reduction
Risk Identification
Review Events
Risk Acceptance
Initiate
Quality Risk Management Process
Output / Result of the
Quality Risk Management Process
R
is
k
Ma
nag
e
m
ent
tools
R
is
k
C
o
m
m
u
n
ic
ation
T
eam
foc
us
ed
Internal
consu
ltation
S
takeho
lder
involvement
Q9 Risk Based Approach (2005)
23. manag
Fundamentals of Q10
Development Tech Transfer Discontinue
Commercial
Supply
Monitoring
Systems
CAPA
Systems
Management
Review
Change
Management
Quality Risk
Management
Knowledge
Management
GMP
24. Integrity
Uniformity
Weight Control
In vitro
Dissolution
Chemical
Purity
API, Excipients, Manufacturing Process
Pharmaceutics
Profile
API Particle Size
API Salt Selection
Chemical
Compatibility
Degradation
Pathway
Prediction
Material Property
Characterization
Process Simulation
Design
Christopher Sinko, Ph.D.
Pfizer Global Research &
Development
Knowledge Management Example:
Quality By Design
25. manag
Fundamentals of Q10
Development Tech Transfer Discontinue
Commercial
Supply
Monitoring
Systems
CAPA
Systems
Management
Review
Change
Management
Quality Risk
Management
Knowledge
Management
SENIOR MANAGEMENT RESPONSIBILITY
GMP
26. Q10 Management Responsibilities for a
Pharmaceutical Quality System (P4 Section 2)
• Senior Management has ultimate responsibility
• Have to participate
• Demonstrate strong & visible support
• Effective communication to appropriate levels of management
• Define roles, responsibilities authorities & inter-relationships
• Conduct Management reviews of product Quality, Process
performance & Pharmaceutical Quality System performance
• Advocate continual improvement
• Commit appropriate resource
Why do we need more guidance when the is all covered in
GMP – refer section 1.1.2 & 1.1.3 of the GMP Guide ?
29. IMPLEMENTATION REALITIES
• The guidance specifically states that:
"ICH Q10 is not intended to create any new expectations
beyond current regulatory requirements", and anything
within ICH Q10 that is additional to current GMP
requirements is "optional" rather than obligatory
• Implementation of these initiatives on top of current
“rules based Quality Management Systems” will drown
your Company in additional Resources and associated
expenses
• Re-implementation of your Quality Management System
based on these initiatives can create innovative ways to
explore the latest efficiency improvements while still
complying to GMP
30. Quality System Implementation
Start End
Management
Team
Leadership
High
Low
Advice on how NOT to start
Kick Off Fanfare
Get System Ready
Management Team will
See Value and Integrate
Into Daily Performance
31. Quality System Implementation
Start End
Management
Team
Leadership
High
Low
Advice on What Works
Kick Off Fanfare
Get System Ready
Integrate into
Business Objectives STOP
Management Team see
Value and have Integrated
Into Daily Performance
32. Advice on approaches that work
• The Head of the Unit and not the QA Manager/RP has to
be seen as the driver of any implementation (think like a
fox!)
• Always have a separate meeting (called by Head) to
discuss the status of your QMS until implementation is
complete: paradox- NOT at normal management meetings as QMS
issues will be diluted by “more important issues”
• STOP and wait if you have to – Sub optimization leads to
negative perceptions of value & results in management doubts
• A good Quality System should eventually be the backbone of a
“Business Excellence System” but if it gets weighed down too
early it will breakdown – Allow it to get strong before adding
additional “modules” - irony: As the management team get excited they will
want to use it for more (and break it) so you have to defend the system until the entire
system is strong enough (and mature enough) to take on more processes
33. Summary
• ICH Q10 requires an understanding of FDA for the 21st
Century, ICH Q8 (Design), ICH Q9 (Risk) as well as ISO
9000 (2005) to maximize benefit
• ICH Q10 is an ISO SYSTEMS approach to GMP
• NOT additional to GMP but integral to GMP
• Covers full life Cycle of a Product
• Objectives: Product Realization, Control & Improvement
• DEMANDS Management Team to lead Quality System
• Seek compliance only and you will get compliance only
• The toughest implementation battles are internal so look
for internal Allies before going outside for support
35. References
• References
• GMP for the 21st century
www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm
• International Conference on Harmonisation, ICH Q8:
Pharmaceutical Development, November 2005.
http://www.ich.org/
• International Conference on Harmonisation, ICH Q9: Quality Risk
Management, November 2005. http://www.ich.org/
• International Conference on Harmonisation, Draft Consensus
Guideline, ICH Q10: Pharmaceutical Quality System, May 2007.
http://www.ich.org/
• FDA, Guidance for Industry: Quality Systems Approach to
Pharmaceutical CGMP Regulations, September 2006.
http://www.fda.gov/
• 01 January 2008By:Adrian KirkPharmaceutical Technology Europe
